SIDDHI PATEL
HASBROUK HEIGHTS,NJ
Summary
-Experience in Clinical Trial Operations and TMF support for Phase II and III Clinical Trials
-Maintained Timelines, Quality, and Completeness of TMF
-Experience in project management activities- from site feasibility, Study start-up, monitoring, and site close-out activities.
-Experience in site monitoring visits.
-Draft, Review, distribute and manage study-related documents.
-Participate in meetings and record meeting minutes.
-Track patient recruitment and PRN visits for the study.
-Working knowledge of ICH/GCP guidelines and FDA regulations
-Experience in vendor management.
Overview
12
12
years of professional experience
Work History
Associate Clinical Trial Manager
Hookipa Pharma
New York, NY
10.2022 - Current
- Under the supervision of the Clinical Trial Manager, support Clinical Operations, duties, and responsibilities relative to the management of Clinical Research studies will include, but will not be limited to:
- Manage and coordinate the Clinical trial activities with the CRO.
- Review study plans and ensure their timely update.
- Review Monitoring reports.
- Review action item logs and ensure all action items are closed in a timely manner.
- Review the Risk Log and ensure the risks are reviewed and updated in a timely manner.
- Support imaging and biosample vendors in resolving queries.
- Responsible for vendor management activities.
- Updating/reviewing study training materials.
- Communicate with CRO regarding project timelines, updates, needs, and emerging issues.
- Follow screening and recruitment activities to ensure timely enrollment in the studies.
- Review and manage study budgets. Collaborate with the cross-functional team to ensure the billing unit is in agreement with the activities performed.
- Review site budget.
- Support Trial Manager with reviewing, tracking, and managing site start-up activities.
- Review Vendor tracker tools and manuals.
- Support Clinical Scientist with Tumor tracking and assessment.
- Support CTM with site issues and escalation.
- Responsible for drafting/ reviewing site materials eg mass mailing, Lab eblast etc
- Maintain ct.gov updates.
- Support with site audit/ inspection preparedness.
- Support Biomarker with site sample tracking logistics & management.
- eTMF Oversight.
Senior CTA
ICON Clinical Research
Hasbrouck Heights, NJ
08.2021 - 10.2022
- Support the study operational strategies.
- Ensure eTMF oversight including routine quality checks to maintain a complete and inspection-ready state.
- Work with the clinical operations team to maintain clinical trial study metrics for routine review
- Assist clinical sites with questions.
- Maintain site & study level protocol information in Trial Management Systems (e.g. Veeva Vault).
- Update subject related status in CTMS.
- In liaison with the Trial Managers, ensure current versions of the required trial documents, trial-related materials, and supplies are provided to the investigational site within required timeframes.
- Partner with the Trial Managers and CRAs to ensure overall site management and adherence to internal SOPs, policies, and local regulatory requirements.
- Conduct an Annual quality review of the study.
- Conduct Quarterly quality reviews of the vendor systems.
- Support the Clinical Research Associate team with tasks including; tracking, filling, collating and verifying, for completeness, clinical documentation
- Assist the team with progress tracking by updating the relevant ICON/Sponsor tracking system
- Set, up, organize and maintain department electronic filing systems. Organize and attend meetings as requested and assist in the production of slides, overheads etc as needed
- Assist in the co-ordination of site payments
- Mentor and train junior members of the CTA team
Clinical Trial Associate/Clinical Research Associate
Global Clinical Trials LLC
Princeton, NJ
04.2021 - 08.2021
- Responsible for Creating/maintaining essential document trackers like Master Study documents list, Study Start up trackers, Vendor Trackers, Site staff contact list trackers, Feasibility Trackers.
- Provided Trial Master File (TMF) support for clinical operations team by scanning, uploading and indexing documents to Veeva Vault.
- Responsible for sending CDA/NDA along with protocol synopsis to sites as Master site list, routing CDA/NDA to responsible personnel for signature.
- Reviews the quality and integrity of patient data at assigned sites through the remote review of electronic case report form (CRF) data.
- Responsible for project management activities- site feasibility, Study start-up, monitoring, and site closeout activities.
- Responsible for taking meeting minutes and distribution
clinical operations meeting Agenda. - Attend team meetings (prepare and distribute agenda and
minutes) and enter and maintain data in the CTMS system per the
guidance of the project team. - Essential document collection and management, collection of
source documents. - Responsible for collection of essential documents like IRB
approval, PSP, IB AOR, Lab certifications, 1572, PI CV, ML, FDF and
ICH-GCP certification. - Responsible for performing initial Quality check on essential documents and uploading into Veeva Vault.
- Communicate with the sites related to subject PRN visits, EDC queries, ensuring everyone has smooth access to the EDC.
- Support team with Inhouse CRA related duties when the CRA's are on monitoring visits.
- Request for site audits.
- Constantly support sites and sponsor for the issues and escalate it to the concerned person or department.
- Responsible to Communicate with sites on issues escalated
related to clinical supplies and prepare, review, and approve site
regulatory documents.
Clinical Research-Volunteer
RWJ - Rutgers
New Brunswick, NJ
12.2020 - 03.2021
- Performed source document verification.
- Managed study-related binders.
- Reviewed of site regulatory documentation in accordance to Standard Operating Procedures, Good Clinical Practice and regulatory guidelines.
- Performed multiple clinical site source document auditing.(3 sites)
- Review Patient Information Sheet /Informed Consent Forms (PIS/ICFs)
- Ensured Informed consent form is collected from all subjects as per protocol.
- Assisted regulatory coordinator in reviewing regulatory binders.
Operations Manager
Anita Dongre
New York, NY
08.2018 - 03.2021
- Administration, management, hiring and onboarding of new staff, accounting, ecommerce and logistics were my core responsibilities.
Research Associate
Anand Agricultural University
Anand, Gujrat
06.2012 - 08.2012
- Did research on molecular characterization of rice (Oryza Sativa L.) genotypes with varying pericarp color using INDEL and SSR markers.
Education
Master of Science - Clinical Research Management - Ongoing
Rutgers, The State University of New Jersey
Newark, NJ05.2022
Pharmaceutical Management Certification -
Ecornell
2019
Master of Science - Biotechnology
Ramnarainan Ruia College
Mumbai,India2012
Bachelor of Science - Biotechnology
Mahaveer Jain College
Bangalore India2010
Skills
- Study Startup
- Feasibility Study
- TMF management-paper & electronic
- Review study plans
- Vendor Management
- Update study Material
- IMednet, Medidata,Inform, Wingspan, Veeva Vault, Flex, RedCap
- Regulatory document management
- Certified ICH-GCP
- Preparing for Monitoring Visits-Qualification,SIV & Site monitoring
- Review Monitoring Reports
- MS Excel, Word & PowerPoint
- Site Auditing
- Budget Review
- Data Entry
- Query management
- Time Management
Timeline
Associate Clinical Trial Manager
Hookipa Pharma
10.2022 - Current
Senior CTA
ICON Clinical Research
08.2021 - 10.2022
Clinical Trial Associate/Clinical Research Associate
Global Clinical Trials LLC
04.2021 - 08.2021
Clinical Research-Volunteer
RWJ - Rutgers
12.2020 - 03.2021
Operations Manager
Anita Dongre
08.2018 - 03.2021
Research Associate
Anand Agricultural University
06.2012 - 08.2012
Master of Science - Clinical Research Management - Ongoing
Rutgers, The State University of New Jersey
Pharmaceutical Management Certification -
Ecornell
Master of Science - Biotechnology
Ramnarainan Ruia College
Bachelor of Science - Biotechnology
Mahaveer Jain College
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